Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

NCT04311099 | Completed Phase 4 DMC

• 1 other identifier: OPMICS-1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Conditions

Pain, Postoperative; Pain, Abdominal; Analgesia; Surgery; Colon Cancer; Injection Site

Outcome Measures

Primary Outcomes (1)

• Total morphine dose equivalents administered.

  Intravenously in milligrams.

  The first 24 hours from the end of anesthesia.

Secondary Outcomes (13)

• Total morphine dose equivalents administered in the operation theater.

  Up to 12 hours.

• Total morphine dose equivalents administered in the post anesthesia care unit.

  The first 24 hours from the end of anesthesia.

• Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.

  Postoperative Day 1.

• Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1

  Postoperative Day 1.

• Postoperative length of stay.

  Up to 30 days.

Study Arms (3)

Ultrasound-guided TAP

EXPERIMENTAL

Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Drug: Active drug; Drug: Placebo; Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block; Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block

Laparoscopic assisted TAP

EXPERIMENTAL

Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Drug: Active drug; Drug: Placebo; Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block; Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block

Placebo

PLACEBO COMPARATOR

Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Drug: Placebo; Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block; Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block

Interventions

Active drug DRUG

Injection of Ropivacaine

Also known as: Ropivacaine

Laparoscopic assisted TAP; Ultrasound-guided TAP

Placebo DRUG

Injection of Saline solution

Also known as: Saline solution

Laparoscopic assisted TAP; Placebo; Ultrasound-guided TAP

Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block PROCEDURE

Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Ultrasound-guided TAP

Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block PROCEDURE

Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Laparoscopic assisted TAP

Injection of placebo - Ultrasound-guided transverse abdominal plane block PROCEDURE

Lateral ultrasound-guided transverse abdominal plane block with saline solution

Laparoscopic assisted TAP; Placebo

Injection of placebo - Laparoscopic assisted transverse abdominal plane block PROCEDURE

Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Placebo; Ultrasound-guided TAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. The following procedural codes are included:
• Laparoscopic ileocecal resection
• Laparoscopic right hemicolectomy
• Other laparoscopic resection of both small and large bowel
• Laparoscopic resection of transverse colon
• Laparoscopic left hemicolectomy
• Laparoscopic resection of sigmoid colon
• Other laparoscopic colon resection
• Having given informed written consent.

You may not qualify if:

• Known allergy to local analgesics
• Known liver failure Class C according to the Child-Pugh Score
• Body weight of less than 40 kg
• History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)
• Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia
• Predictably non-compliant due to language barrier or psychiatric disease
• Patients rescheduled for open surgery, before the intervention has been administered
• Patients where the indication for surgery changes before the intervention has been administered
• Patients with known inflammatory bowel disease
• Patients who have previously undergone open major abdominal surgery defined by prior intraabdominal surgery with a midline or upper abdominal incision of more than 8 cm
• Incisional hernia
• Patients with a history of abdominal wall surgery including resection of the external oblique muscles, the internal oblique muscles, the transversus abdominis muscles, the rectus abdominis muscles or their fascial components
• Pregnancy (patients are screened using urine human chorionic gonadotropin upon admission if female and not postmenopausal).

Sponsors & Collaborators

• Claus Anders Bertelsen, PhD, MD: lead

Study Sites (5)

Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

Location

Regionshospitalet Herning

Herning, 7400, Denmark

Location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Copenhagen University Hospital - Hvidovre

Hvidovre, 2650, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (25)

• Lund H, Spanager L, Winther ACR, Gierloff M, Sunekaer K, Kleif J, Bertelsen CA. Recurrence and complications after laparoscopic inguinal hernia repair using a self-adherent mesh: a patient-reported follow-up study. Surg Endosc. 2025 Apr;39(4):2464-2470. doi: 10.1007/s00464-025-11614-7. Epub 2025 Feb 24.

  PMID: 39994048 BACKGROUND

• Salmonsen CB, Lange KHW, Kleif J, Kroijer R, Bruun L, Mikalonis M, Dalsgaard P, Hesseldal KB, Olsson JEP, Bertelsen CA; OPMICS Study Group. Transversus abdominis plane block in minimally invasive colon surgery: a multicenter three-arm randomized controlled superiority and non-inferiority clinical trial. Reg Anesth Pain Med. 2025 Jan 23:rapm-2024-105712. doi: 10.1136/rapm-2024-105712. Online ahead of print.

  PMID: 39542642 BACKGROUND

• Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.

  PMID: 28742427 BACKGROUND

• Grant MC, Yang D, Wu CL, Makary MA, Wick EC. Impact of Enhanced Recovery After Surgery and Fast Track Surgery Pathways on Healthcare-associated Infections: Results From a Systematic Review and Meta-analysis. Ann Surg. 2017 Jan;265(1):68-79. doi: 10.1097/SLA.0000000000001703.

  PMID: 28009729 BACKGROUND

• Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.

  PMID: 22632762 BACKGROUND

• Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.

  PMID: 20216019 BACKGROUND

• Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.

  PMID: 27429253 BACKGROUND

• Keller DS, Madhoun N, Ponte-Moreno OI, Ibarra S, Haas EM. Transversus abdominis plane blocks: pilot of feasibility and the learning curve. J Surg Res. 2016 Jul;204(1):101-8. doi: 10.1016/j.jss.2016.04.012. Epub 2016 Apr 27.

  PMID: 27451874 BACKGROUND

• Keller DS, Ermlich BO, Schiltz N, Champagne BJ, Reynolds HL Jr, Stein SL, Delaney CP. The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial. Dis Colon Rectum. 2014 Nov;57(11):1290-7. doi: 10.1097/DCR.0000000000000211.

  PMID: 25285696 BACKGROUND

• Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.

  PMID: 23355160 BACKGROUND

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 BACKGROUND

• Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.

  PMID: 21401554 BACKGROUND

• Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.

  PMID: 25899736 BACKGROUND

• Park SY, Park JS, Choi GS, Kim HJ, Moon S, Yeo J. Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Operation: A Randomized, Single-Blind, Non-Inferiority Trial. J Am Coll Surg. 2017 Sep;225(3):403-410. doi: 10.1016/j.jamcollsurg.2017.05.017. Epub 2017 Jun 10.

  PMID: 28610880 BACKGROUND

• Zaghiyan KN, Mendelson BJ, Eng MR, Ovsepyan G, Mirocha JM, Fleshner P. Randomized Clinical Trial Comparing Laparoscopic Versus Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colorectal Surgery. Dis Colon Rectum. 2019 Feb;62(2):203-210. doi: 10.1097/DCR.0000000000001292.

  PMID: 30540660 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Dickerson DM, Apfelbaum JL. Local anesthetic systemic toxicity. Aesthet Surg J. 2014 Sep;34(7):1111-9. doi: 10.1177/1090820X14543102. Epub 2014 Jul 15.

  PMID: 25028740 BACKGROUND

• Naidu RK, Richebe P. Probable local anesthetic systemic toxicity in a postpartum patient with acute Fatty liver of pregnancy after a transversus abdominis plane block. A A Case Rep. 2013 Dec 1;1(5):72-4. doi: 10.1097/ACC.0b013e3182973a2f.

  PMID: 25612087 BACKGROUND

• Statzer N, Cummings KC 3rd. Transversus Abdominis Plane Blocks. Adv Anesth. 2018 Dec;36(1):163-180. doi: 10.1016/j.aan.2018.07.007. Epub 2018 Sep 27. No abstract available.

  PMID: 30414636 BACKGROUND

• Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.

  PMID: 28085788 BACKGROUND

• Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524.

  BACKGROUND

• Salmonsen CB, Lange KHW, Kleif J, Bertelsen CA. Optimal peripheral nerve block after minimally invasive colon surgery - a study protocol for a randomised trial. Dan Med J. 2021 Nov 12;68(12):A03210245.

  PMID: 34851250 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Abdominal Pain; Agnosia; Colonic Neoplasms

Interventions

Bulk Drugs; Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Claus A Bertelsen, PhD

  Copenhagen University Hospital - North Zealand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor, consultant surgeon

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 17, 2020
• Study Start: January 14, 2021
• Primary Completion: February 8, 2024
• Study Completion: March 31, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For 15 years after publication
• Access Criteria: A methodologically sound proposal for meta-analyses

Locations

DK (5)